Evaluating A Non-Invasive Tissue Perfusion Monitor
2020年11月13日 更新者:Pedra Technology, PTE LTD
A Feasibility Study Evaluating A Non-Invasive Tissue Perfusion Monitor Utilising Diffuse Speckle Contrast Analysis
The Pedra perfusion system will be used to assess changes in perfusion in response to physiological stimuli.
It will be compared to other standard diagnostics.
研究概览
详细说明
The Pedra perfusion system measures microvascular flow through diffuse speckle contrast analysis.
It will be used to assess changes in perfusion in response to a number of physiological stimuli.
It will be compared to other standard diagnostics including ankle-brachial index, toe-brachial index and transcutaneous oxygen measurement.
Measurements will be undertaken in non-vascular patients as well as those with chronic limb threatening ischaemia.
研究类型
观察性的
注册 (预期的)
50
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients with palpable pulses and patients with chronic limb threatening ischaemia
描述
Inclusion Criteria:
CLTI cohort
- At least 40 years old
- Each patient will have documented arterial occlusive disease within 6 weeks of enrolment as determined by an ankle-brachial index (ABI) < 0.7 but not greater than 1.2, toe-brachial index (TBI) <0.5, skin perfusion pressure (SPP) less than 30mmHg, OR Transcutaneous oxygen measurement (TCOM) < 40mmHg in diabetics and <30mmHg in non-diabetics.
- The presence of skin breakdown compatible which with an underlying ischemic element (previous minor amputation for gangrene also included) that the Principle Investigator (PI) deems appropriate for the study.
- Subject has read, understood and signed approved consent, and is willing to participate and comply with the study procedures and requirements.
Non-vascular group
- At least 40 years old
- Each patient will have documented palpable foot pulses
- 21 patients will be free of lower limb oedema and 6 patients will have moderate oedema present
- Subject has read, understood and signed approved consent, and is willing to participate and comply with the study procedures and requirements.
Exclusion Criteria:
CLTI Cohort
- Subject on an investigational drug or therapeutic device within 30 days of the study visit, which in the view of the PI may compromise the study results.
- Presence of a condition that PI considers will compromise the subject's ability to participate in the study.
- Age <40 or >90
- Inability to straight leg raise to 30 degrees or tolerate calf cuff occlusion.
- Has smoked cigarettes/e-cigarettes on the day of testing.
- Has taken caffeine drinks on the day of testing
- In the last 3 hours the subject has exercised beyond normal daily walking.
- Inability to have TBI measured (e.g. absence of toe)
- Signs of active infection causing localised inflammation on the plantar or dorsal surfaces of the foot
- Pathological skin conditions that may impair the ability of the adhesive sensor pads to adhere.
Non-vascular Cohort
- Subject on an investigational drug or therapeutic device within 30 days of the study visit, which in the view of the PI may compromise the study results.
- Presence of a condition that PI considers will compromise the subject's ability to participate in the study.
- Age <40 or >90
- Inability to straight leg raise to 30 degrees or tolerate calf cuff occlusion.
- Has smoked cigarettes/e-cigarettes on the day of testing.
- Has taken caffeine drinks on the day of testing
- In the last 3 hours the subject has exercised beyond normal daily walking.
- Inability to have TBI measured (e.g. absence of toe)
- Signs of active infection causing localised inflammation on the plantar or dorsal surfaces of the foot
- Pathological skin conditions that may impair the ability of the adhesive sensor pads to adhere.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 观测模型:病例对照
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
---|---|
Non vascular repeatibility
This cohort of patients with palpable pulses will be used to test inter- and intra- observer variability for the Pedra system
|
Diffuse speckle contrast analysis perfusion system
|
Non vascular physiology
This cohort of patients with palpable pulses will assess the ability of Pedra to detect perfusion changes in response to physiologic stimuli.
|
Diffuse speckle contrast analysis perfusion system
|
CLTI physiology
This cohort of patients with CLTI will assess the ability of Pedra to detect perfusion changes in response to physiologic stimuli.
|
Diffuse speckle contrast analysis perfusion system
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
The Blood Perfusion Index (unitless number) delta in response to reduction in arterial inflow pressure
大体时间:Intra-procedure
|
The range of change in the Blood Perfusion Index (unitless) in response to physiologic changes in arterial perfusion, in patients with healthy circulation and those with compromised arterial circulation
|
Intra-procedure
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Reliability of Blood Perfusion Index measurement will be assessed on repeated measures by determination of the correlation coefficient
大体时间:intra-procedure
|
The reliability of measurement of the Blood Perfusion Index will be measured and compared to standard diagnostics
|
intra-procedure
|
Repeatability of Blood Perfusion Index measurement will be assessed on repeated measures by determination of the correlation coefficient
大体时间:intra-procedure
|
The repeatability of measurement of the Blood Perfusion Index will be measured and compared to standard diagnostics
|
intra-procedure
|
Sensitivity of Pedra to detect differences in the Blood Perfusion Index between patient subsets
大体时间:Intra-procedure
|
Use of a ROC curve to assess the ability of the Blood Perfusion Index to differentiate between those with healthy circulation and those with arterial disease
|
Intra-procedure
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2020年12月7日
初级完成 (预期的)
2021年4月1日
研究完成 (预期的)
2021年7月1日
研究注册日期
首次提交
2020年11月5日
首先提交符合 QC 标准的
2020年11月13日
首次发布 (实际的)
2020年11月16日
研究记录更新
最后更新发布 (实际的)
2020年11月16日
上次提交的符合 QC 标准的更新
2020年11月13日
最后验证
2020年11月1日
更多信息
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